Uses For Cetrotide

Cetrorelixis a man-made hormone that blocks the effects of Gonadotropin Releasing Hormone (GnRH). GnRH controls another hormone that is called luteinizing hormone (LH), which is the hormone that starts ovulation during the menstrual cycle. When undergoing hormone treatment sometimes premature ovulation can occur, leading to eggs that are not ready for fertilization to be released. Cetrorelix does not allow the premature release of these eggs to occur.

This medicine is available only with your doctor's prescription.

Before Using Cetrotide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

Cetrorelix is not intended for use in patients over the age of 65 years.

Pregnancy

Pregnancy Category

Explanation

All Trimesters

X

Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Kidney disease—May increase your chance of side effects from cetrorelix.

Proper Use of Cetrotide

Take this medicine only as directed by your doctor. If you are to begin on Day 5, count the first day of your menstrual period as Day 1. Beginning on Day 5, take the correct dose every day for as many days as your doctor ordered. To help you to remember to take your dose of medicine, take it at the same time every day.

Read the paper with information for the patient carefully.

Understand and use the proper method of safely preparing the medicine.

Wash your hands with soap and water and use a clean work area to prepare your injection.

Make sure you clearly understand and carefully follow your doctor's instructions on how to give yourself an injection, including using the proper needle and syringe. Remember to change the site of injection to different areas to prevent skin problems from developing.

Throw away needles, syringes, bottles, and unused medicine after the injection in a safe manner.

Tell your doctor when you use the last dose of cetrorelix . Cetrorelix often requires that another hormone called human chorionic gonadotropin (hCG) be given as a single dose the day after the last dose of cetrorelix is given. Your doctor will give you this medicine or arrange for you to get this medicine at the right time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form:

For treatment of female infertility:

Adults—3 milligrams (mg) injected under the skin one time on Day 7 of your menstrual cycle, or 0.25 mg injected under the skin starting on Day 5 or 6 of your menstrual cycle and continuing until HCG administration occurs.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the 0.25 mg vials in the refrigerator. Store the 3 mg vials at room temperature.

Precautions While Using Cetrotide

It is very important that your doctor check you using ultrasound examination at regular visits to make sure that you are ready for injection with another drug (HCG) to induce ovulation.

Call your doctor immediately if you have taken more of the medication than your doctor ordered..

Cetrotide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Abdominal or stomach pain

continuing or severe nausea, vomiting or diarrhea

decreased amount of urine

feeling of indigestion

moderate to severe bloating

pelvic pain, severe

rapid weight gain

shortness of breath

swelling of lower legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

injection site bruising, itching, swelling, or redness

nausea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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